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Nutritional-GI Completed with Results

ASSURE: Study of Relizorb in people with CF who receive enteral tube feeding (Alcresta 0000498)

This study evaluated the safety, tolerability and effectiveness of RELiZORB® cartridge. RELiZORB® cartridge is a digestive enzyme cartridge for people using enteral nutrition (EN) tube feedings that breaks down fats in enteral nutrition tube feeding formula.

 In this open-label study, all participants used RELiZORB®. Participants started the study in a 7-day observation period where they received their usual EN tube feeding including pancreatic enzyme replacement therapy (PERT). Participants then entered a 7-day run-in period where they received their normal amount of EN formula but used a standard Peptamen 1.5® formula in place of their usual formula. Following the run-in period, participants entered a 90-day treatment period where they received 500 mL to 1,000 mL of Impact Peptide 1.5®, a formula with a higher amount of fatty acids. A single RELiZORB® cartridge was used for each overnight feed. Participants did not use PERT with the overnight EN feedings.

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    4 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    Less than 100%

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

Other Primary Eligibility Criteria

Enteral formula user a minimum of four to five times per week, using PERT, consuming an unrestricted fat diet, and willing to use Peptamen 1.5 and Impact Peptide 1.5

Study Results

  • What We Learned:

    This study found that RELiZORB® was overall safe and well-tolerated and associated with improvements in the omega-3 index, a measure of two fatty acids that have an important role in brain development and counteracting the inflammatory responses of CF. One adverse event, constipation, was related to the RELiZORB® device. Abdominal pain and gas were the most commonly reported symptoms when using RELiZORB®.

  • Primary Findings:

    Effectiveness:

    This study was conducted between July 20th, 2016 and March 30th, 2017. Of the 44 patients enrolled, 36 completed the study. Participants who didn’t complete the study either discontinued before the treatment period (n=5), did not follow the protocol procedures (n=2) or had an adverse event unrelated to the study that resulted in discontinuation (n=1).

     

    The primary efficacy outcome was the change in omega-3 index. This index measures the amount of two fatty acids (eicosapentaenoic acid (EPA) and docosahexaenoic acids (DHA)) in red blood cell membranes. The fatty acids EPA and DHA are important because they counteract the inflammatory responses of CF and are essential to brain development and cognition. This study found that the omega-3 index increased from a baseline value of 4.4% to 9.4% at 90 days (p<0.001). Target range for the omega-3 index is 8%.

     

    Additional evaluations found that there was an increase in the amount of EPA and DHA when measured in the structure of the red blood cell membrane as well as the plasma of the cell. Body mass index (BMI) did not change significantly over the course of the study period.

    Safety:

    Overall, RELiZORB® was safe and well-tolerated. In the treatment period, a single adverse event (AE) of constipation was reported and was thought to be possibly related to the RELiZORB® device. No AEs resulted in discontinuation of using RELiZORB®.

  • Citation:

    J Pediatr Gastroenterol Nutr ;DOI 10.1097/MPG.0000000000002110 [Epub ahead of print]

For current information about the overall development status of this drug, please check the Drug Development Pipeline.

Study Design

  • Study Type: ?more info

    Interventional

  • Randomized Study: ?more info

    No

  • Placebo Controlled: ?more info

    No

  • Length of Participation:

    4 months

  • Number of Study Visits:

    5

Additional Information

  • Phase: ?more info

    Not Applicable

  • Study Sponsor: ?more info

    Alcresta

  • Study Drugs:

    N/A

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    4 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    Less than 100%

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

Other Primary Eligibility Criteria

Enteral formula user a minimum of four to five times per week, using PERT, consuming an unrestricted fat diet, and willing to use Peptamen 1.5 and Impact Peptide 1.5

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